ES2507558T3 - Apparatus and method for treating body tissues with electricity or medications - Google Patents

Abstract

Device (3) implantable for treating body tissue without requiring a connection with the outside of the patient's body, comprising: a) a housing (4) provided with a medication storage compartment (5); b) an oscillating element (7) attached to the housing (4) and communicating with the medication storage compartment (5), the oscillating element (7) being adapted to oscillate in response to ultrasonic stimulation (8); c) a medication opening (9) disposed on the housing (4) and in fluid communication with the medication storage compartment (5), the medication opening (9) being adapted to allow a medication (6) to be introduced ) and is contained in the medication storage compartment (5) and further adapted to selectively release the medication (6) from the medication storage compartment (5) in response to oscillations of the oscillating element (7), in the that the medication opening (9) is an elastic butterfly valve.

Description

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APPARATUS AND METHOD TO TREAT BODY FABRICS WITH ELECTRICITY OR MEDICATIONS DESCRIPTION

Field of the Invention

The present invention relates generally to devices that are implanted within the body of an animal or living human being to confer a therapeutic benefit to a target tissue. More particularly this invention relates to a device and method for selectively electrically stimulating body tissues or organs and also for selectively administering a medicament to a target tissue or organ. It is also the intention of this invention to provide improved treatment by reducing the time between the detection of a specific activity within the tissue or organ being treated and the onset of administration of the electrical stimulus or drug drug to the site of the detected activity.

Background of the invention

Many disorders, for example, brain disorders and certain types of paralysis, are treated by an electrical stimulus or local drug administered to specific sites in the brain or body. A disadvantage of conventional treatment devices and procedures is that conventional treatment devices are large and their placement can cause damage to the patient. Another disadvantage of conventional treatment devices and procedures is that the devices are often implanted and must remain connected to the outside for their power supply or control signals. Another disadvantage of conventional devices and procedures is that administration of the drug to the target tissue may cause trauma to the patient and may not be precisely administered to the target tissue. Another disadvantage of conventional procedures is that the physical connection to the outside and repeated trauma to the patient required by repeated invasion and introduction of foreign objects into the tissue increases the likelihood of infection. Yet another disadvantage of conventional devices and procedures is that they do not provide precise time control of the administration of the electrical stimulus or drug in response to phenomena that occur in, and to stimuli generated by, the tissue or organ being treated that indicate the need for the administration of an electrical stimulus or drug of this type.

EP 0 495 531 A1 discloses an edermal application kit for the external application of medicaments, which comprises a drug-containing layer arranged next to an ultrasonic oscillator. The absorption of the medicament by the skin is guaranteed by the action of the oscillator's ultrasonic waves and the release of the drug can be controlled by varying the oscillator's ultrasonic wave output. This document discloses the most relevant prior art.

US 5,797,898 provides microchips that control both the rate and time of release of multiple chemicals and that allow the release of a wide variety of molecules either continuously or pulsatile. The deposits are etched on a substrate and are covered with materials that either degrade or allow the molecules to passively diffuse out of the tank over time or materials that oxidize and dissolve after the application of an electrical potential . The release from an active device can be controlled by a preprogrammed microprocessor, remote control or by biosensors. A signal, such as radio waves, low power lasers or ultrasound is sent by an external source, for example, computers or ultrasonic generators to the receiver. The signal is sent to the microprocessor where it is transferred to a deposit address.

US 5,411,535 discloses an improved cardiac pacemaker to reduce weight and size and to alleviate the load of the pacemaker carrier ensuring safe signal transmission. The cardiac pacemaker includes a main body of cardiac pacemaker that has at least two electrodes to detect cardiac information, a control section to perform a pulse emitting control based on cardiac information, and a transmission section to modulate the pulses and transmit the pulses modulated The pacemaker also has a stimulation electrode part that has a reception section to receive the transmitted pulses and stimulate the electrodes activated by the pulses leaving the reception section. On the receiving side, the supersonic wave is converted into an electrical signal (voltage) using for example a piezoelectric material. The supersonic wave is preferably used in a frequency band of the order of MHz because it is necessary for it to propagate well through the body.

An object of this invention is to provide an apparatus that selectively applies an electrical stimulus over a period of time to a target tissue of the organism, for example, the brain, without creating a large lesion in the target area and without requiring a connection with the outside, that is, outside the patient's body. A selective stimulus means that a stimulus is specific in time and geometry and can be triggered by tissue activity at the specific location.

Another object of this disclosure is to provide an apparatus and method for selectively administering a

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medication over a period of time to a target tissue of the body, for example, the brain, without creating a large lesion in the target area and without requiring a connection with the outside, that is, outside the patient's body.

Still another object of this disclosure is to provide a method of treating body tissue, which comprises the steps of preparing a device that can generate electrical current at a therapeutic amperage and voltage in response to ultrasonic vibrations; arrange the device in the vicinity of the tissue to be treated; and subjecting the device to ultrasonic vibrations in an amount and for a period of time sufficient for the device to generate electrical currents at therapeutic amperage and voltage.

A further object of this disclosure is to provide a device for treating body tissue, which comprises a housing provided with a medication storage compartment. An oscillating element is attached to the housing and communicates with the medication storage compartment and is adapted to oscillate in response to ultrasonic stimulation. A medication opening is disposed on the housing and is in fluid communication with the medication storage compartment and is adapted to allow a medication to be introduced and contained in the compartment. The medication opening is further adapted to selectively release the medication from the medication storage compartment in response to oscillations of the oscillating element that produce a "pumping" action to pump the medication out of the compartment in response to stimulation of high external frequency

It is still a further object of this disclosure to provide a method of treating body tissue, which comprises the steps of preparing a device comprising a housing provided with a medicament storage compartment. An oscillating element is attached to the housing and is in fluid communication with the medication storage compartment and is adapted to oscillate in response to ultrasonic stimulation. A medication opening is disposed on the housing and communicates with the medication storage compartment and is adapted to allow a medication to be introduced and contained in the compartment. The medication opening is further adapted to selectively release the medication from the medication storage compartment in response to oscillations of the oscillating element. In operation, a medication is introduced through the medication opening and into the medication storage compartment. The device is arranged in the vicinity of the tissue to be treated and is subjected to ultrasonic vibrations in an amount and for a period of time sufficient for the oscillating element to oscillate in an amount and for a period of time to cause the desired amount of medication is discharged from the medication storage compartment through the medication opening to the tissue to be treated.

Still another object of this disclosure is to provide a sensor or a series of sensors that communicate with a tissue or organ that is being treated, for example, the brain. The sensors communicate with one or more actuators adapted to selectively administer a predetermined amount of an electrical impulse or a medication to the tissue or organ being treated in response to the detected stimulus generated by the tissue or organ being treated indicating the need of the administration of an electrical impulse or medication of this type. In a particularly preferred embodiment, stimulation is detected in a tissue, for example, the brain

or a nerve and stimulation occurs in a different tissue, for example, the paralyzed muscle of a leg.

The invention is defined in claim 1.

Brief description of the drawings

Figure 1 shows a device constructed to apply electrical stimulation to a target tissue;

Figure 2 shows a device constructed to administer a medication to a target tissue;

Figure 3 shows an alternative embodiment of the device shown in Figure 1;

Figure 4 shows an alternative embodiment of the device shown in Figure 2;

Figure 5 shows an alternative embodiment of the device shown in Figure 1; Y;

Figure 6 shows an alternative embodiment of the device shown in Figure 2; Y

Figure 7 shows an alternative embodiment of a device constructed to deliver a medicament to a target tissue.

Detailed description of the invention

Miniature oscillating ceramic (OCM) motors are well known in the art and are disclosed in US Patent 5,453,653 to Zumeris, the specification. These engines can be manufactured very small and in any way and work by contacting a surface in an amount sufficient to

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generate enough friction to allow the motor to “drag” along the surface in contact and change its position in relation to the surface in contact when the motor is activated. These motors can be adequately insulated to act in aqueous environments. Their small size and low energy level requirements make them especially suitable for use in living organisms.

Figure 1 shows an embodiment of a ceramic motor used according to the disclosure to provide electrical stimulation to a target tissue. The electrical stimulation device 1 is provided with electrodes 2. In normal use, electricity is applied to the electrodes 2 which causes the electrical stimulation device 1 to generate oscillations in the ultrasonic range. It is well known that if a conventional electric motor is started, it will produce electricity. Similarly, if the ceramic motor is vibrated ultrasonically, an electric current will be generated and discharged from the electrodes 2. The ceramic motor operates according to the second piezoelectric effect, and conversely, the current generation by vibrating the Ceramic is equivalent to the first piezoelectric effect. The frequencies used in the various embodiments of this disclosure may be varied as dictated by specific applications. A wide range of frequencies can be used, for example, radiofrequency (rf) or ultrasound (us), depending on the type and location of the tissue being treated and the type and amount of tissue through which the vibrations must pass high frequency

Stimulation of nerve cells in the brain system and in any other part of the body is desirable for the treatment of different disorders, for example, the activation of muscles whose biological activation is altered. In application, the device will be delivered to the target area to be treated, for example, the brain, using conventional procedures such as catheter delivery or surgical implant. Because the electrical stimulation device 1 is small, there is minimal trauma to the patient. In addition, because the electrical stimulation device 1 is left in place, there is a reduced probability of complications or tissue damage that may result from repeated invasion, for example, by needles or electrodes introduced and repeatedly removed from the area. Diana. In addition, because there is no need for the electrical stimulation device 1 to remain connected to the outside after implantation, there is a reduced probability of complications, for example, infection, which may result from the connection with the outside.

Once the electrical stimulation device 1 is in place, it is subjected to ultrasonic energy 8 from means 10 to selectively generate ultrasonic vibrations 8 which causes the electrical stimulation device 1 to vibrate and generate electricity from the electrodes 2 The electrodes 2 can be sized and arranged in the device as dictated by specific applications to maximize the effectiveness of the treatment. The electrical stimulation device 1 and the treatment time can be modified to generate electricity at a desired voltage and amperage and for a desired period of time as dictated by specific applications.

Figure 2 shows a medication delivery device 3 constructed according to the invention. Figure 2 shows that the medication delivery device 3 is provided with a housing 4 provided with a medication storage compartment 5 for storing a medication 6. The housing 4 is also provided with an oscillating element 7 constructed of a material that is adapted to oscillate in response to 8 ultrasonic stimulation. The oscillating element 7 communicates with the medication storage compartment 5 so that the oscillating element 7 will come into contact with a medicament 6 stored in the medication storage compartment 5. The housing 4 is also provided with a medicament opening 9 in fluid communication with the medication storage compartment 5. The medication opening 9 is adapted to allow a medication 6 to be inserted into the medication storage compartment 5 and is further adapted to allow the medication 6 to be discharged from the medication storage compartment 5 when the oscillating element 7 oscillates. An elastic butterfly valve shown in Figure 2 is used.

In operation, the doctor will introduce the medication 6 into the medication storage compartment 5 through the medication opening 9. The medication delivery device 3 is then introduced into the target zone using conventional procedures as discussed above. As shown in Figure 2, the physician can subject the medication delivery device 3 to ultrasonic energy 8 generated by means 10 to selectively generate and transmit ultrasonic vibrations 8 to the oscillating element 7. The ultrasonic energy 8 that strikes the oscillating element 7 causes the oscillating element 7 to oscillate as shown in Figure 2. This causes the desired amount of medication 6 to be discharged from the medication storage compartment 5 through the opening 9 of medication to the target area. The amount of time that device 3 is exposed to ultrasonic vibration 8 can be varied as dictated by specific applications and will depend on factors such as the target area to be treated, the amount of medication 6 to be administered and the composition, for example, solid or liquid and / or the viscosity of the medicine 6.

By using both the electrical stimulation device 1 and the medication delivery device 3, the means 10 for generating the ultrasonic vibrations can be operated manually, can be programmed to generate ultrasonic vibrations for a predetermined fixed period of time, for example, 10 seconds, at predetermined fixed intervals, for example, every hour, or can be activated automatically in response to signals received from a sensor 11.

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In an especially preferred embodiment, one or more sensors 11 are used in conjunction with devices 1 and 3 as shown in Figures 1 to 6 to monitor the tissue being treated for a variety of preselected physiological activities and parameters indicating the need for treatment and the amount of treatment required. These physiological activities and parameters include, for example, but are not limited to, changes in neurological activity, temperature, pressure, discharge of fluid from the target area, chemical composition of the discharge and chemical changes in the tissue being treated.

The sensor or sensors 11 can be implanted at various points on or in the tissue or organ being treated as dictated by the specific applications. Alternatively, the sensor 11 can be arranged on devices 1 and 3 as shown in Figures 3-6. The sensor 11 is adapted to communicate with means 10 to selectively generate and transmit ultrasonic vibrations 8 as discussed above. The communication 13 between the sensor 11 and the means 10 for generating ultrasonic vibrations 8 can be direct, for example, by means of an electric cable, however, in a preferred embodiment the communication 13 takes place by radio transmission. The radio radio communication between the sensor 11 and the means 10 for generating ultrasonic vibrations reduces discomfort for the patient and also reduces the likelihood of infection because a wired connection is not required.

In operation, the sensor 11 monitors physiological parameters of the tissue or organ being treated and detects changes in these physiological parameters. After detecting a change, the sensor 11 sends a signal to the means 10 to generate ultrasonic vibrations 8. In response to the signal received from the sensor 11, the means 10 for generating ultrasonic vibrations 8 generates an ultrasonic signal 8 for a period of time sufficient for the device to administer the desired treatment to the tissue or organ being treated as discussed above. . The period of time in which the ultrasonic signal 8 is generated can be set or can be varied selectively depending on the physiological change detected by the sensor 11 and can be varied depending on the type and degree of the physiological change detected by the sensor 11. In a Especially preferred embodiment, the means 10 for generating the ultrasonic vibration 8 can be provided with means 12 for calculating the amount of electricity or medicament required by the tissue or organ being treated depending on the type and degree of physiological change detected. The variation of the duration of the generated ultrasonic vibration 8 varies and controls the amount of electricity or medication administered to the tissue or organ being treated. Therefore, this embodiment provides a self-administration and self-administration system that quickly calculates the amount of treatment required and provides rapid administration of the required amount of treatment to the target area. The means 10 for generating the ultrasonic vibration 8 may also be arranged on the devices 1 and 3 as shown in Figures 5 and 6 to provide a single piece monitoring, dosing and administration system.

Alternatively, the detection can be performed on a tissue, for example, the brain or a nerve and the stimulation can be performed on a different tissue, for example, a paralyzed muscle.

The devices and methods of this invention can be modified and adapted for a wide range of treatments as dictated by specific circumstances, and more specifically in a particularly preferred embodiment, in cases of paralysis. For example, if a person's leg were paralyzed, a stimulator could be provided that would communicate with the leg muscles. The stimulator would generate a stimulus for the muscles in response to a sensor that could be located in, or communicate with, for example, the person's arm. The sensor could be adapted to be sensitive to the movements of the individual's arm. Therefore, when the individual wanted to activate the muscles of his leg he could do so by voluntarily moving his arm a predetermined distance or in a predetermined direction. The sensor in the arm would detect the movement of the arm and generate a signal that would communicate with the stimulator that communicates with the muscles in the person's leg. This allows the person to selectively generate a stimulus for the muscles and allows the person to selectively activate the muscles in their leg.

Figure 7 shows the medication delivery device 3 constructed according to the disclosure for administering a medication to a target tissue. Figure 7 shows that the medication delivery device 14 is provided with a housing 15 provided with one or more bubbles 16 of the medication storage compartment for storing a medicament 6. The bubbles 16 are constructed of a material well known to those skilled in the art. in the technique that is selected and adapted to break in response to ultrasonic stimulation 8. The housing 15 may also be provided with one or more medicament openings 17 in fluid communication with the bubbles 16 of the medication storage compartment. The medication openings 17 are adapted to allow a medicament 6 to be introduced into the medication storage compartment bubbles 16. For this purpose, a wide variety of openings or valves known to those skilled in the art can be used as discussed above.

In operation, the doctor will introduce the medication 6 into the bubbles 16 of the medication storage compartment through the medication opening 17. The medication delivery device 14 is then introduced into the target zone using conventional procedures as discussed above. The physician may selectively subject the medication delivery device 14 to

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ultrasonic energy as discussed above. The ultrasonic energy that strikes the bubbles 16 causes the bubbles 16 to break. This causes the desired amount of medication 6 to be discharged from the bubbles 16 of the medication storage compartment to the target area. The amount of time that device 14 is exposed to ultrasonic vibration can be varied as dictated by applications.

5 specific and will depend on factors such as the target area to be treated, the amount of medication 6 to be administered, the composition, for example, solid or liquid and / or the viscosity of the medication 6, and the type of material used to make the storage compartment bubbles 16. In an alternative embodiment, the medication opening is not used. Instead, the medicament 6 is disposed between the housing 15 and the bubbles 16 before the bubbles 16 are attached to the housing 15.

The devices of this invention provide minimally invasive drug and electrical stimulation of tissue with reduced risk of complications, for example, infection, which may result from conventional procedures. Although the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention can be made.

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Claims (5)

E08008616 09-26-2014 1. Implantable device (3) for treating body tissue without requiring a connection with the outside of the patient's body, comprising: 5 a) a housing (4) provided with a medication storage compartment (5); b) an oscillating element (7) attached to the housing (4) and communicating with the medication storage compartment (5), the oscillating element (7) being adapted to oscillate in response to 10 (8) ultrasonic stimulation; c) a medication opening (9) disposed on the housing (4) and in fluid communication with the medication storage compartment (5), the medication opening (9) being adapted to allow a medication (6) to be introduced ) and is contained in the medication storage compartment (5) and further adapted to selectively release the medication (6) from the medication storage compartment (5) in response to oscillations of the element (7) oscillating, wherein the medication opening (9) is an elastic butterfly valve. twenty 2. Device for treating body tissue according to claim 1, further comprising: d) sensor means (11), the sensor means (11) being adapted to receive preselected stimuli generated by the body tissue, the sensor means (11) being adapted to 25 communicate with and selectively activate means (10) for selectively generating and transmitting ultrasonic vibrations to the oscillating element (7) in response to the preselected stimuli generated by body tissue. 3. Device according to claim 2, further comprising means (12) for calculating the duration of the 30 ultrasonic frequency depending on the type and degree of physiological change detected by the sensor, communicating the means (12) to calculate with the sensor (11) and with the means (10) to generate and transmit ultrasonic vibrations selectively. 4. Device for treating body tissue according to claim 1, further comprising; D) means (10) for selectively generating and transmitting ultrasonic vibrations to the oscillating element, the means (10) being arranged for generating and transmitting the ultrasonic vibrations on the housing; Y e) sensor means (11), the sensor means being adapted to receive preselected stimuli 40 generated by the body tissue, the sensor means (11) being adapted to communicate with and selectively activate the means (10) to selectively generate and transmit ultrasonic vibrations to the oscillating element (7) in response to the preselected stimuli generated by body tissue. Device according to claim 2, wherein the sensor means (11) are arranged on the device. 6. Device according to claim 2, wherein the means (11) for generating and transmitting in a manner Selective ultrasonic vibrations are provided with means to calculate the amount of medication 50 required by said tissue depending on the type and degree of physiological change detected. 7